Methods for deploying intraocular shunts

ABSTRACT

The present invention generally relates to methods for deploying intraocular shunts without the use of an optical apparatus that contacts an eye, such as a goniolens. In certain embodiments, methods of the invention involve inserting into an eye a deployment device configured to hold an intraocular shunt, determining that a distal portion of the device is properly positioned within the eye without use of an optical apparatus that contacts the eye, and deploying the shunt from the device.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of International Patent ApplicationNo. PCT/US2011/060820, filed on Nov. 15, 2011, entitled METHODS FORDEPLOYING INTRAOCULAR SHUNTS, which claims the benefit of and priorityto U.S. patent application Ser. No. 12/946,210, filed on Nov. 15, 2010,the content of both of which is incorporated by reference herein in itsentirety.

FIELD OF THE INVENTION

The present invention generally relates to methods for deployingintraocular shunts without the use of an optical apparatus that contactsan eye, such as a goniolens.

BACKGROUND

Glaucoma is a disease of the eye that affects millions of people.Glaucoma is associated with an increase in intraocular pressureresulting either from a failure of a drainage system of an eye toadequately remove aqueous humor from an anterior chamber of the eye oroverproduction of aqueous humor by a ciliary body in the eye. Build-upof aqueous humor and resulting intraocular pressure may result inirreversible damage to the optic nerve and the retina, which may lead toirreversible retinal damage and blindness.

Glaucoma may be treated by surgical intervention that involves placing ashunt in the eye to result in production of fluid flow pathways betweenthe anterior chamber and various structures of the eye involved inaqueous humor drainage (e.g., Schlemm's canal, the sclera, or thesubconjunctival space). Such fluid flow pathways allow for aqueous humorto exit the anterior chamber. Generally, the surgical intervention toimplant the shunt involves inserting into the eye a delivery device thatholds an intraocular shunt, and deploying the shunt within the eye. Adelivery device holding the shunt enters the eye through a cornea (abinterno approach), and is advanced across the anterior chamber. Thedelivery device is advanced through the sclera until a distal portion ofthe device is in proximity to a drainage structure of the eye. The shuntis then deployed from the delivery device, producing a conduit betweenthe anterior chamber and various structures of the eye involved inaqueous humor drainage (e.g., Schlemm's canal, the sclera, or thesubconjunctival space). See for example, Yu et al. (U.S. Pat. No.6,544,249 and U.S. patent application number 2008/0108933) and Prywes(U.S. Pat. No. 6,007,511).

Such a surgical procedure requires an optical apparatus, such as agoniolens, so that a surgeon may visualize the delivery device withinthe eye and ensure proper placement of the shunt after it has beendeployed from the delivery device.

SUMMARY

The present invention generally relates to methods for deployingintraocular shunts from a delivery device without use of an opticalapparatus that contacts the eye, preferably without use of any opticalapparatus. Methods of the invention may be accomplished by usingresistance feedback to inform an operator that a delivery device isproperly positioned within an eye for deployment and proper placement ofthe shunt within the eye.

In particular embodiments, methods of the invention involve insertinginto an eye a deployment device configured to hold an intraocular shunt,determining that a distal portion of the device is properly positionedwithin the eye without use of an optical apparatus that contacts theeye, and deploying the shunt from the device. In certain embodiments,determining involves advancing the device until a resistance isencountered. The resistance indicates to an operator that a distal endof the device has advanced across the anterior chamber of the eye andthat a distal portion of the device is fitted within an anterior chamberangle of the eye, and is thereby properly positioned for deployment ofthe intraocular shunt.

Deploying the shunt results in a flow path from an anterior chamber ofthe eye to an area of low pressure. Exemplary areas of lower pressureinclude intra-tenon's space, the subconjunctival space, the episcleralvein, the suprachoroidal space, or Schlemm's canal. In certainembodiments, the area of lower pressure is the subarachnoid space.

Another aspect of the invention provides methods for deploying a shuntwithin an eye including inserting into an eye a deployment deviceconfigured to hold an intraocular shunt, advancing the device until aprotrusion on a distal end of a housing of the device contacts ananterior chamber angle of the eye, thereby providing resistance againstfurther advancement of the device, and deploying the shunt from thedevice. In certain embodiments, a distal portion of the housingcomprises a sleeve and a hollow shaft that is movable within the sleeve.

The protrusion may be formed integrally with the distal end of thesleeve or may be connected to a distal end of the sleeve. The protrusionmay surround the distal end of the sleeve, or the protrusion may extendaround only a portion of the sleeve. In certain embodiments, theprotrusion is a collar that surrounds the distal end of the sleeve. Inother embodiments, the protrusion includes a flat bottom portion and anangled top portion. In particular embodiments, the angle of the topportion is substantially identical to an anterior chamber angle of aneye.

Methods of the invention are typically conducted using an ab internoapproach. Such an approach is contrasted with an ab externo approach,which involves inserting the shaft through the conjunctiva of the eye.Although, methods of the invention may be conducted using an ab externoapproach.

Methods of the invention may be performed such that the shaft isinserted above or below the corneal limbus. Methods of the invention maybe performed such that the shaft is inserted into the eye withoutremoving an anatomical feature of the eye, such as the trabecularmeshwork, the iris, the cornea, and the aqueous humor. In certainembodiments, methods of the invention may be conducted withoutsubstantial subconjunctival blebbing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic showing an embodiment of a shunt deploymentdevice according to the invention. FIG. 1B shows a cross sectional viewof the device of FIG. 1. In this figure, the distal portion of thehousing is extended from the proximal portion of the housing. FIG. 1Cshows a cross sectional view of the device of FIG. 1. In this figure,the distal portion of the housing is retracted within the proximalportion of the housing. FIG. 1D is a schematic showing an enlarged viewof a protrusion on a distal end of a distal portion of a housing of thedevice of FIG. 1A. In this figure, a bottom portion of the protrusion isflat and a top portion of the protrusion is angled.

FIGS. 2A-2C are schematics showing an enlarged view of a protrusion on adistal end of a distal portion of a housing of devices of the invention.FIG. 2B is a side view of the protrusion shown in FIG. 2A. FIG. 2C is atop view of the protrusion shown in FIG. 2A.

FIG. 3A shows a deployment device in an insertion configuration and fitinto an anterior chamber of an eye. FIG. 3B shows a deployment device inan insertion configuration and inserted at too shallow an angled, thusabutting the sclera above the anterior chamber angle. FIG. 3C shows adeployment device in an insertion configuration after the protrusion hascaused the device to slide down the sclera and be fit into an anteriorchamber of an eye. FIG. 3D shows a deployment device in an insertionconfiguration and inserted at too steep an angled, thus abutting theiris below the anterior chamber angle. FIG. 3E shows a deployment devicein an insertion configuration after the protrusion has caused the deviceto deflect off of the iris and slide along the iris and be fit into ananterior chamber of an eye.

FIG. 4 shows an exploded view of the device shown in FIG. 1.

FIGS. 5A to 5D are schematics showing different enlarged views of thedeployment mechanism of the deployment device.

FIGS. 6A to 6C are schematics showing interaction of the deploymentmechanism with a portion of the housing of the deployment device.

FIG. 7 depicts a schematic of an exemplary intraocular shunt.

FIG. 8 shows a cross sectional view of the deployment mechanism of thedeployment device.

FIG. 9A is a schematic showing deployment devices of the invention in apre-deployment or insertion configuration. FIG. 9B shows an enlargedview of the distal portion of the deployment device of FIG. 9A. Thisfigure shows an intraocular shunt loaded within a hollow shaft of thedeployment device and that the shaft is completely disposed within thesleeve of the housing. FIG. 9C show a schematic of the deploymentmechanism in a pre-deployment or insertion configuration. FIG. 9D isanother schematic showing deployment devices of the invention in apre-deployment or insertion configuration.

FIG. 10 is a schematic showing insertion of a device of the inventioninto an anterior chamber of the eye. This figure also shows the sleeveand protrusion fitted within an anterior chamber angle of the eye.

FIG. 11 is a schematic showing extension of the shaft from within thesleeve, which is accomplished by partial retraction of the distalportion of housing to within the proximal portion of housing.

FIGS. 12A and 12B show schematics of the deployment mechanism at the endof the first stage of deployment of the shunt from the deploymentdevice. FIG. 12C shows an enlarged view of the distal portion of thedeployment device of FIG. 12A. This figure shows an intraocular shuntpartially deployed from within a hollow shaft of the deployment device.

FIG. 13 is a schematic showing the deployment device after completion ofthe first stage of deployment of the shunt from the device and in to theeye.

FIG. 14A show a schematic of the deployment mechanism at the end of thesecond stage of deployment. FIG. 14B shows a schematic of the deploymentdevice at the end of the second stage of deployment. FIG. 14C showsanother view of the deployment device at the end of the second stage ofdeployment.

FIG. 15 is a schematic showing the deployment device after completion ofdeployment of the shunt from the device and in to the eye.

DETAILED DESCRIPTION

Reference is now made to FIG. 1A which shows an embodiment of a shuntdeployment device 100 according to the invention. While FIG. 1 shows ahandheld manually operated shunt deployment device, it will beappreciated that devices of the invention may be coupled with roboticsystems and may be completely or partially automated. As shown in FIG.1A deployment device 100 includes a generally cylindrical body orhousing 101, however, the body shape of housing 101 could be other thancylindrical. Housing 101 may have an ergonomical shape, allowing forcomfortable grasping by an operator. Housing 101 is shown with optionalgrooves 102 to allow for easier gripping by a surgeon.

FIG. 1B shows a cross sectional view of device 100. This figure showsthat housing 101 includes a proximal portion 101 a and a distal portion101 b. The distal portion 101 b is movable within proximal portion 101a. In this figure, spring mechanism 120 includes a spring 121 thatcontrols movement of distal portion 101 b. Spring mechanism 120 furtherincludes a member 122 that acts as a stopper and limits axial retractionof distal portion 101 b within proximal portion 101 a. Spring mechanism120 further includes members 123 and 124 that run the length of spring121. The ends of members 123 and 124 include flanges 125 and 126 thatproject inward from members 123 and 124. An end of distal portion 101 bincludes flanges 127 and 128 that project outward from distal portion101 b. Flanges 125 and 126 interact with flanges 127 and 128 to preventrelease of distal portion 101 b from proximal portion 101 a. The flanges125 and 126 and 127 and 128 hold the distal portion 101 b in an extendedposition until a compressive force acts upon distal portion 101 b,thereby causing distal portion 101 b to partially retract withinproximal portion 101 a.

Distal portion 101 b includes a capsule 129 and a hollow sleeve 130.Capsule 129 and sleeve 130 may be formed integrally or may be separatecomponents that are coupled or connected to each other. The hollowsleeve 130 is configured for insertion into an eye and to extend into ananterior chamber of an eye. FIG. 1B shows distal portion 101 b ofhousing 101 extended from proximal portion 101 a of housing 101. In thisconfiguration, hollow shaft 104 (not shown in this figure) is completelydisposed within sleeve 130. FIG. 1C shows distal portion 101 b ofhousing 101 retracted within proximal portion 101 a of housing 101.Retraction of distal portion 101 b of housing 101 within proximalportion 101 a of housing 101 exposes hollow shaft 104, which isdiscussed in greater detail below.

A distal end of sleeve 130 includes a protrusion 131 (FIG. 1D).Protrusion 131 provides resistance feedback to an operator as theoperator is advancing the sleeve 130 through an anterior chamber of aneye. In a standard ab interno approach (see for example Yu et al. U.S.Pat. No. 6,544,249 and U.S. patent application number 2008/0108933) adeployment device holding a shunt enters an eye through a cornea. Thedeployment device is advanced across the anterior chamber in what isreferred to as a transpupil implant insertion. The deployment device isadvanced to the sclera on the opposite side of the eye from which thedevice entered the eye. With devices of the invention, upon advancementof the device 100 across an anterior chamber of the eye, the protrusion131 at the distal end of the hollow sleeve 130 will contact the sclera,providing resistance feedback to an operator that no further advancementof the device 100 is necessary. This feedback also informs the operatorthat the device 100 is in proper position for exposure of the hollowshaft 104, which will advance through the sclera for deployment of anintraocular shunt. The protrusion 131, provides adequate surface area atthe distal end of sleeve 130, thus preventing sleeve 130 from enteringthe sclera.

In certain embodiments, protrusion 131 has a substantially flat bottomportion and an angled top portion (FIG. 1D). In other embodiments,protrusion 131 has a slightly tapered top and a slightly tapered bottomwith a rounded distal portion (FIGS. 2A-2C).

Referring back to FIG. 1D, the angle of the top portion is substantiallyidentical to an anterior chamber angle of an eye. Such a shape of theprotrusion ensures that the device of the invention will also finds itsway to fit into the anterior chamber angle of the eye, the place forproper deployment of an intraocular shunt. This is explained withreference to FIGS. 3A to 3E. FIG. 3A shows device 100 in an insertionconfiguration and inserted into an eye 140. In this figure, protrusion131 at the distal end of the sleeve 130 has been advanced across theanterior chamber 141 to the sclera 142 on the opposite side of the eye140 from which the device entered the eye 140. FIG. 3A shows protrusion131 fitted within the anterior chamber angle 143 of the eye 140. Ifsleeve 130 enters the anterior chamber 141 at too shallow an angle,i.e., the protrusion 131 hit the sclera 142 above the anterior chamberangle 143, the angled top portion of the protrusion 131 causes thesleeve 130 to slide down the sclera 142 (direction of arrow) until theprotrusion 131 is fit within the anterior chamber angle 143 of the eye140 (FIGS. 3B and 3C). The sleeve 130 will slide down the sclera 142instead of entering the sclera 142 at the contact point because theshaft 104 is completely disposed within the sleeve 130 and theprotrusion 131 provides adequate surface area at the distal end ofsleeve 130 to prevent enough force from being generated at the distalend of sleeve 130 that would result in sleeve 130 entering the sclera142.

Conversely, if sleeve 130 enters the anterior chamber 141 at too steepan angle, i.e., the protrusion 131 hit the iris 144 below the anteriorchamber angle 143, the substantially flat bottom portion of theprotrusion 131 causes the sleeve 130 to deflect off the iris 144 andproceed is a direction parallel to the iris 144 until the protrusion 131is fit within the anterior chamber angle 143 of the eye 140 (FIGS. 3Dand 3E). The sleeve 130 will deflect off the iris 144 instead ofentering the iris 144 at the contact point because the shaft 104 iscompletely disposed within the sleeve 130 and the protrusion 131provides adequate surface area at the distal end of sleeve 130 toprevent enough force from being generated at the distal end of sleeve130 that would result in sleeve 130 entering the iris 144.

In certain embodiments, protrusion 131 is not required. In theseembodiments, the sleeve 130 is of a sufficient outer diameter such thatthe sleeve itself may serve the function of the protrusion as describedabove. In these embodiments, a distal end of the sleeve is shaped tohave a flat bottom portion and an angled top portion.

Referring back to FIG. 1A, the proximal portion 101 a of the housing 101is open at its proximal end, such that a portion of a deploymentmechanism 103 may extend from the proximal end of the proximal portion101 a of the housing 101. The sleeve 130 of the distal portion 101 b ofthe housing 101 is also open such that at least a portion of a hollowshaft 104 may extend inside the housing, into sleeve 130 of the distalportion 101 b of the housing 101, and extend beyond the distal end ofthe sleeve 130 in certain configurations (such as the deploymentconfiguration). Housing 101 further includes a slot 106 through which anoperator, such as a surgeon, using the device 100 may view an indicator107 on the deployment mechanism 103.

Housing 101 and protrusion 131 may be made of any material that issuitable for use in medical devices. For example, housing 101 andprotrusion 131 may be made of a lightweight aluminum or a biocompatibleplastic material. Examples of such suitable plastic materials includepolycarbonate and other polymeric resins such as DELRIN and ULTEM. Incertain embodiments, housing 101 and protrusion 131 are made of amaterial that may be autoclaved, and thus allow for housing 101 andprotrusion 131 to be re-usable. Alternatively, device 100, may be soldas a one-time-use device, and thus the material of the housing and theprotrusion does not need to be a material that is autoclavable.

The proximal portion 101 a of housing 101 may be made of multiplecomponents that connect together to form the housing. FIG. 4 shows anexploded view of deployment device 100. In this figure, proximal portion101 a of housing 101, is shown having two components 101 a 1 and 101 a2. The components are designed to screw together to form proximalportion 101 a of housing 101. FIG. 5 also shows deployment mechanism103. The housing 101 is designed such that deployment mechanism 103 fitswithin assembled housing 101. Housing 101 is designed such thatcomponents of deployment mechanism 103 are movable within housing 101.

FIGS. 5A to 5D show different enlarged views of the deployment mechanism103. Deployment mechanism 103 may be made of any material that issuitable for use in medical devices. For example, deployment mechanism103 may be made of a lightweight aluminum or a biocompatible plasticmaterial. Examples of such suitable plastic materials includepolycarbonate and other polymeric resins such as DELRIN and ULTEM. Incertain embodiments, deployment mechanism 103 is made of a material thatmay be autoclaved, and thus allow for deployment mechanism 103 to bere-usable. Alternatively, device 100 may be sold as a one-time-usedevice, and thus the material of the deployment mechanism does not needto be a material that is autoclavable.

Deployment mechanism 103 includes a distal portion 109 and a proximalportion 110. The deployment mechanism 103 is configured such that distalportion 109 is movable within proximal portion 110. More particularly,distal portion 109 is capable of partially retracting to within proximalportion 110.

In this embodiment, the distal portion 109 is shown to taper to aconnection with a hollow shaft 104. This embodiment is illustrated suchthat the connection between the hollow shaft 104 and the distal portion109 of the deployment mechanism 103 occurs inside the housing 101.Hollow shaft 104 may be removable from the distal portion 109 of thedeployment mechanism 103. Alternatively, the hollow shaft 104 may bepermanently coupled to the distal portion 109 of the deploymentmechanism 103.

Generally, hollow shaft 104 is configured to hold an intraocular shunt115. An exemplary intraocular shunt 115 in shown in FIG. 7. Otherexemplary intraocular shunts are shown in Yu et al. (U.S. patentapplication number 2008/0108933). Generally, in one embodiment,intraocular shunts are of a cylindrical shape and have an outsidecylindrical wall and a hollow interior. The shunt may have an innerdiameter of approximately 50 μm to approximately 250 μm, an outsidediameter of approximately 190 μm to approximately 300 μm, and a lengthof approximately 0.5 mm to about 20 mm. Thus, hollow shaft 104 isconfigured to at least hold a shunt of such shape and such dimensions.However, hollow shaft 104 may be configured to hold shunts of differentshapes and different dimensions than those described above, and theinvention encompasses a shaft 104 that may be configured to hold anyshaped or dimensioned intraocular shunt. In particular embodiments, theshaft has an inner diameter of approximately 200 μm to approximately 400μm.

The shaft 104 may be any length. A usable length of the shaft may beanywhere from about 5 mm to about 40 mm, and is 15 mm in certainembodiments. In certain embodiments, the shaft is straight. In otherembodiments, shaft 104 is of a shape other than straight, for example ashaft having a bend along its length or a shaft having an arcuateportion. Exemplary shaped shafts are shown for example in Yu et al.(U.S. patent application number 2008/0108933). In particularembodiments, the shaft includes a bend at a distal portion of the shaft.In other embodiments, a distal end of the shaft is beveled or issharpened to a point.

The shaft 104 may hold the shunt at least partially within the hollowinterior of the shaft 104. In other embodiments, the shunt is heldcompletely within the hollow interior of the shaft 104. Alternatively,the hollow shaft may hold the shunt on an outer surface of the shaft104. In particular embodiments, the shunt is held within the hollowinterior of the shaft 104. In certain embodiments, the hollow shaft is aneedle having a hollow interior. Needles that are configured to hold anintraocular shunt are commercially available from Terumo Medical Corp.(Elkington, Md.).

A proximal portion of the deployment mechanism 103 includes optionalgrooves 116 to allow for easier gripping by an operator for easierrotation of the deployment mechanism, which will be discussed in moredetail below. The proximal portion 110 of the deployment mechanism alsoincludes at least one indicator that provides feedback to an operator asto the state of the deployment mechanism. The indicator may be any typeof indicator known in the art, for example a visual indicator, an audioindicator, or a tactile indicator. FIG. 5 shows a deployment mechanismhaving two indicators, a ready indicator 111 and a deployed indicator119. Ready indicator 111 provides feedback to an operator that thedeployment mechanism is in a configuration for deployment of anintraocular shunt from the deployment device 100. The indicator 111 isshown in this embodiment as a green oval having a triangle within theoval. Deployed indicator 119 provides feedback to the operator that thedeployment mechanism has been fully engaged and has deployed the shuntfrom the deployment device 100. The deployed indicator 119 is shown inthis embodiment as a yellow oval having a black square within the oval.The indicators are located on the deployment mechanism such that whenassembled, the indicators 111 and 119 may be seen through slot 106 inhousing 101.

The proximal portion 110 includes a stationary portion 110 b and arotating portion 110 a. The proximal portion 110 includes a channel 112that runs part of the length of stationary portion 110 b and the entirelength of rotating portion 110 a. The channel 112 is configured tointeract with a protrusion 117 on an interior portion of housingcomponent 101 a (FIGS. 6A and 6B). During assembly, the protrusion 117on housing component 101 a 1 is aligned with channel 112 on thestationary portion 110 b and rotating portion 110 a of the deploymentmechanism 103. The proximal portion 110 of deployment mechanism 103 isslid within housing component 101 a 1 until the protrusion 117 sitswithin stationary portion 110 b (FIG. 6C). Assembled, the protrusion 117interacts with the stationary portion 110 b of the deployment mechanism103 and prevents rotation of stationary portion 110 b. In thisconfiguration, rotating portion 110 a is free to rotate within housingcomponent 101 a 1.

Referring back to FIG. 5, the rotating portion 110 a of proximal portion110 of deployment mechanism 103 also includes channels 113 a, 113 b, and113 c. Channel 113 a includes a first portion 113 a 1 that is straightand runs perpendicular to the length of the rotating portion 110 a, anda second portion 113 a 2 that runs diagonally along the length ofrotating portion 110 a, downwardly toward a proximal end of thedeployment mechanism 103. Channel 113 b includes a first portion 113 b 1that runs diagonally along the length of the rotating portion 110 a,downwardly toward a distal end of the deployment mechanism 103, and asecond portion that is straight and runs perpendicular to the length ofthe rotating portion 110 a. The point at which first portion 113 a 1transitions to second portion 113 a 2 along channel 113 a, is the sameas the point at which first portion 113 b 1 transitions to secondportion 113 b 2 along channel 113 b. Channel 113 c is straight and runsperpendicular to the length of the rotating portion 110 a. Within eachof channels 113 a, 113 b, and 113 c, sit members 114 a, 114 b, and 114 crespectively. Members 114 a, 114 b, and 114 c are movable withinchannels 113 a, 113 b, and 113 c. Members 114 a, 114 b, and 114 c alsoact as stoppers that limit movement of rotating portion 110 a, whichthereby limits axial movement of the shaft 104.

FIG. 8 shows a cross-sectional view of deployment mechanism 103. Member114 a is connected to the distal portion 109 of the deployment mechanism103. Movement of member 114 a results in retraction of the distalportion 109 of the deployment mechanism 103 to within the proximalportion 110 of the deployment mechanism 103. Member 114 b is connectedto a pusher component 118. The pusher component 118 extends through thedistal portion 109 of the deployment mechanism 103 and extends into aportion of hollow shaft 104. The pusher component is involved indeployment of a shunt from the hollow shaft 104. An exemplary pushercomponent is a plunger. Movement of member 114 b engages pusher 118 andresults in pusher 118 advancing within hollow shaft 104.

Reference is now made to FIGS. 9-15, which accompany the followingdiscussion regarding deployment of a shunt 115 from deployment device100. FIG. 9A shows deployment device 100 in a pre-deployment orinsertion configuration. In this configuration, shunt 115 is loadedwithin hollow shaft 104 (FIG. 9B). As shown in FIG. 9B, shunt 115 isonly partially within shaft 104, such that a portion of the shunt isexposed. However, the shunt 115 does not extend beyond the end of theshaft 104. In other embodiments, the shunt 115 is completely disposedwithin hollow shaft 104. The shunt 115 is loaded into hollow shaft 104such that the shunt abuts pusher component 118 within hollow shaft 104.

In the pre-deployment or insertion configuration, the distal portion 101b of the housing 101 is in an extended position, with spring 121 in arelaxed state (FIG. 9A). Additionally, in the pre-deploymentconfiguration, the shaft 104 is fully disposed within the sleeve 130 ofthe distal portion 101 b of the housing 101 (FIG. 9B). Pusher 118 abutsshunt 115 (FIG. 9B).

The deployment mechanism 103 is configured such that member 114 a abutsa distal end of the first portion 113 a 1 of channel 113 a, and member114 b abut a proximal end of the first portion 113 b 1 of channel 113 b(FIG. 9C). In this configuration, the ready indicator 111 is visiblethrough slot 106 of the housing 101, providing feedback to an operatorthat the deployment mechanism is in a configuration for deployment of anintraocular shunt from the deployment device 100 (FIG. 9D). In thisconfiguration, the device 100 is ready for insertion into an eye(insertion configuration or pre-deployment configuration).

FIG. 10 shows device 100 in the insertion configuration and insertedinto an eye 140. Any of a variety of methods known in the art may beused to insert devices of the invention into an eye. In certainembodiments, devices of the invention may be inserted into the eye usingan ab externo approach (entering through the conjunctiva) or an abinterno approach (entering through the cornea). In particularembodiment, the approach is an ab interno approach as shown Yu et al.(U.S. Pat. No. 6,544,249 and U.S. patent application number2008/0108933) and Prywes (U.S. Pat. No. 6,007,511), the content of eachof which is incorporated by reference herein in its entirety.

FIG. 10 shows an ab interno approach for insertion of device 100 intothe eye 140. In this figure, protrusion 131 at the distal end of thesleeve 130 has been advanced across the anterior chamber 141 to thesclera 142 on the opposite side of the eye 140 from which the deviceentered the eye 140. FIG. 10 shows protrusion 131 and sleeve 130 fittedwithin the anterior chamber angle 143 of the eye 140. Such insertion andplacement is accomplished without the use of an optical apparatus thatcontacts the eye, such as a goniolens. In certain embodiments thisinsertion is accomplished without the use of any optical apparatus.

Insertion without the use of an optical apparatus that contacts the eye,or any optical apparatus, is possible because of various features of thedevice described above and reviewed here briefly. The shape of theprotrusion 131 is such that it corrects for an insertion angle that istoo steep or too shallow, ensuring that the sleeve 130 is fitted intothe anterior chamber angle of the eye, the place for proper deploymentof an intraocular shunt. Further, the shape of the protrusion providesadequate surface area at the distal end of sleeve 130 to prevent enoughforce from being generated at the distal end of sleeve 130 that wouldresult in sleeve 130 entering an improper portion of the sclera 142 (ifthe insertion angle is too shallow) or entering an improper portion ofthe iris 144 (if the insertion angle is too steep). Additionally, sincethe shaft 104 is fully disposed within the sleeve 130, it cannot piercetissue of the eye until it is extended from the sleeve 130. Thus, if theinsertion angle is too shallow or too steep, the protrusion 131 cancause movement and repositioning of the sleeve 130 so that the sleeve130 is properly positioned to fit in the anterior chamber angle of theeye for proper deployment of the shunt. Due to these features of device100, devices of the invention provide for deploying intraocular shuntswithout use of an optical apparatus that contacts the eye, preferablywithout use of any optical apparatus.

Once the device has been inserted into the eye and the protrusion 131and the sleeve 130 are fitted within the anterior chamber angle of theeye, the hollow shaft 104 may be extended from within the sleeve 130.Referring now to FIG. 11 which shows extension of the shaft 104 fromwithin the sleeve 130, which is accomplished by partial retraction ofdistal portion 101 b of housing 101 to within proximal portion 101 a ofhousing 101.

Retraction of the distal portion 101 b of housing 101 to within proximalportion 101 a of housing 101 is accomplished by an operator continuingto apply force to advance device 100 after the protrusion 131 and thesleeve 130 are fitted within the anterior chamber angle of the eye. Thesurface area of protrusion 131 prevents the application of theadditional force by the operator from advancing sleeve 130 into thesclera 134. Rather, the additional force applied by the operator resultsin engagement of spring mechanism 120 and compression of spring 121within spring mechanism 120. Compression of spring 120 results inretraction of distal portion 101 b of housing 101 to within proximalportion 101 a of housing 101. The amount of retraction of distal portion101 b of housing 101 to within proximal portion 101 a of housing 101 islimited by member 122 that acts as a stopper and limits axial retractionof distal portion 101 b within proximal portion 101 a.

Retraction of distal portion 101 b of housing 101 to within proximalportion 101 a of housing 101 results in extension of hollow shaft 104,which now extends beyond the distal end of sleeve 130 and advancesthrough the sclera 142 to an area of lower pressure than the anteriorchamber. Exemplary areas of lower pressure include Schlemm's canal, thesubconjunctival space, the episcleral vein, the suprachoroidal space, orthe intra-Tenon's space.

In this figure, a distal end of the shaft is shown to be located withinthe intra-Tenon's space. Within an eye, there is a membrane known as theconjunctiva, and the region below the conjunctiva is known as thesubconjunctival space. Within the subconjunctival space is a membraneknown as Tenon's capsule. Below Tenon's capsule there are Tenon'sadhesions that connect the Tenon's capsule to the sclera. The spacebetween Tenon's capsule and the sclera where the Tenon's adhesionsconnect the Tenon's capsule to the sclera is known as the intra-Tenon'sspace. This figure is exemplary and depicts only one embodiment for alocation of lower pressure. It will be appreciated that devices of theinvention may deploy shunts to various different locations of the eyeand are not limited to deploying shunts to the intra-Tenon's space isshown by way of example in this figure. In this configuration, the shunt115 is still completely disposed within the shaft 104.

The distal end of shaft 104 may be beveled to assist in piercing thesclera and advancing the distal end of the shaft 104 through the sclera.In this figure, the distal end of the shaft 104 is shown to have adouble bevel (See also FIG. 9B). The double bevel provides an angle atthe distal end of the shaft 104 such that upon entry of the shaft intointra-Tenon's space, the distal end of shaft 104 will by parallel withTenon's capsule and will thus not pierce Tenon's capsule and enter thesubconjunctival space. This ensures proper deployment of the shunt suchthat a distal end of the shunt 115 is deployed within the intra-Tenon'sspace, rather than deployment of the distal end of the shunt 115 withinthe subconjunctival space. Changing the angle of the bevel allows forplacement of shunt 115 within other areas of lower pressure than theanterior chamber, such as the subconjunctival space. It will beunderstood that FIG. 12 is merely one embodiment of where shunt 115 maybe placed within the eye, and that devices of the invention are notlimited to placing shunts within intra-Tenon's space and may be used toplace shunts into many other areas of the eye, such as Schlemm's canal,the subconjunctival space, the episcleral vein, or the suprachoroidalspace.

Reference is now made to FIGS. 12A to 12C. After extension of hollowshaft 104 from sleeve 130, the shunt 115 may be deployed from the device100. The deployment mechanism 103 is a two-stage system. The first stageis engagement of the pusher component 118 and the second stage isretraction of the distal portion 109 of deployment mechanism 103 towithin the proximal portion 110 of the deployment mechanism 103.Rotation of the rotating portion 110 a of the proximal portion 110 ofthe deployment mechanism 103 sequentially engages the pusher componentand then the retraction component.

In the first stage of shunt deployment, the pusher component is engagedand the pusher partially deploys the shunt from the deployment device.During the first stage, rotating portion 110 a of the proximal portion110 of the deployment mechanism 103 is rotated, resulting in movement ofmembers 114 a and 114 b along first portions 113 a 1 and 113 b 1 inchannels 113 a and 113 b. Since the first portion 113 a 1 of channel 113a is straight and runs perpendicular to the length of the rotatingportion 110 a, rotation of rotating portion 110 a does not cause axialmovement of member 114 a. Without axial movement of member 114 a, thereis no retraction of the distal portion 109 to within the proximalportion 110 of the deployment mechanism 103. Since the first portion 113b 1 of channel 113 b runs diagonally along the length of the rotatingportion 110 a, upwardly toward a distal end of the deployment mechanism103, rotation of rotating portion 110 a causes axial movement of member114 b toward a distal end of the device. Axial movement of member 114 btoward a distal end of the device results in forward advancement of thepusher component 118 within the hollow shaft 104. Such movement ofpusher component 118 results in partially deployment of the shunt 115from the shaft 104.

FIGS. 12A to 12C show schematics of the deployment mechanism at the endof the first stage of deployment of the shunt from the deploymentdevice. As is shown FIG. 12A, members 114 a and 114 b have finishedtraversing along first portions 113 a 1 and 113 b 1 of channels 113 aand 113 b. Additionally, pusher component 118 has advanced within hollowshaft 104 (FIG. 12B), and shunt 115 has been partially deployed from thehollow shaft 104 (FIG. 12C). As is shown in FIG. 12C, a portion of theshunt 115 extends beyond an end of the shaft 104.

FIG. 13 shows device 100 at the end of the first stage of deployment ofthe shunt 115 from device 100 and into the eye 140. This figure showsthat the distal portion 101 b of the housing 101 remains retractedwithin the proximal portion 101 a of the housing 101, and that the shaft104 remains extended from the sleeve 130. As is shown in this figure,pusher 118 has been engaged and has partially deployed shunt 115 fromshaft 104. As is shown in this figure, a portion of the shunt 115extends beyond an end of the shaft 104 and is located in theintra-Tenon's space.

Reference is now made to FIGS. 14A to 14C. In the second stage of shuntdeployment, the retraction component of deployment mechanism is engagedand the distal portion of the deployment mechanism is retracted towithin the proximal portion of the deployment mechanism, therebycompleting deployment of the shunt from the deployment device. Duringthe second stage, rotating portion 110 a of the proximal portion 110 ofthe deployment mechanism 103 is further rotated, resulting in movementof members 114 a and 114 b along second portions 113 a 2 and 113 b 2 inchannels 113 a and 113 b. Since the second portion 113 b 2 of channel113 b is straight and runs perpendicular to the length of the rotatingportion 110 a, rotation of rotating portion 110 a does not cause axialmovement of member 114 b. Without axial movement of member 114 b, thereis no further advancement of pusher 118. Since the second portion 113 a2 of channel 113 a runs diagonally along the length of the rotatingportion 110 a, downwardly toward a proximal end of the deploymentmechanism 103, rotation of rotating portion 110 a causes axial movementof member 114 a toward a proximal end of the device. Axial movement ofmember 114 a toward a proximal end of the device results in retractionof the distal portion 109 to within the proximal portion 110 of thedeployment mechanism 103. Retraction of the distal portion 109, resultsin retraction of the hollow shaft 104. Since the shunt 115 abuts thepusher component 118, the shunt remains stationary at the hollow shaft104 retracts from around the shunt 115. The shaft 104 retractscompletely to within the sleeve 130 of the distal portion 101 b of thehousing 101. During both stages of the deployment process, the housing101 remains stationary and in a fixed position.

Referring to FIG. 14A, which shows a schematic of the deploymentmechanism at the end of the second stage of deployment of the shunt fromthe deployment device. As is shown in FIG. 14A, members 114 a and 114 bhave finished traversing along second portions 113 a 2 and 113 b 2 ofchannels 113 a and 113 b. Additionally, distal portion 109 has retractedto within proximal portion 110, thus resulting in retraction of thehollow shaft 104 to within the housing 101.

FIG. 14B shows a schematic of the device 100 in the eye 140 after thesecond stage of deployment has been completed. FIG. 14B shows that thedistal portion 101 b of the housing 101 remains retracted within theproximal portion 101 a of the housing 101. As is shown in these FIGS.14B and 14C, shaft 104 has withdrawn through the sclera 134 and hasfully retracted to within sleeve 130. At completion of the second stageof deployment, a distal portion of the shunt 115 has been deployed andresides in the intra-Tenon's space, a middle portion of the shunt 115spans the sclera, and a proximal portion of shunt 115 has been deployedfrom shaft 104 yet still resides within sleeve 130. The proximal portionof the shunt 115 still abuts pusher 118.

Referring to FIG. 14C, in the post-deployment configuration, thedeployed indicator 119 is visible through slot 106 of the housing 101,providing feedback to the operator that the deployment mechanism 103 hasbeen fully engaged and that the deployment mechanism 103 has completedits second stage of deployment.

Referring to FIG. 15, which shows a schematic of the device 100 aftercompletion of deployment of the shunt 115 from the device 100 and in tothe eye 140. After completion of the second stage of the deployment bythe deployment mechanism 103, as indicated to the operator byvisualization of deployed indicator 119 through slot 106 of the housing101, the operator may pull the device 100 from the eye 140. Backwardforce by the operator reengages spring mechanism 120 and results inuncoiling of spring 121. Uncoiling of spring 121 proceeds as theproximal portion 101 a of housing 101 is pulled from the eye 140. Suchaction causes distal portion 101 b to return to its extended statewithin proximal portion 101 a of housing 101. Continued backward forceby the operator continues to pull the device 100 from the eye 140. Asthe device 100 is continued to be pulled from the eye, the sleeve 130 isalso pulled backward and the proximal portion of the shunt 115 isexposed from within the sleeve 130 and resides within the anteriorchamber 141 of the eye 140. The operator continues to apply backwardforce until the device 100 is completely withdrawn from the eye 140.

COMBINATIONS OF EMBODIMENTS

As will be appreciated by one skilled in the art, individual features ofthe invention may be used separately or in any combination.Particularly, it is contemplated that one or more features of theindividually described above embodiments may be combined into a singleshunt.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein.

What is claimed is:
 1. A method for deploying a shunt within an eye, themethod comprising: inserting into an eye a deployment device configuredto hold an intraocular shunt; determining, without use of an opticalapparatus that contacts the eye, that a distal portion of the device isat a position at the anterior chamber angle of the eye; and advancing,from the device at the position, the shunt into eye tissue.
 2. Themethod according to claim 1, wherein the determining comprises advancingthe device until a resistance against further advancement isencountered.
 3. The method according to claim 1, wherein the advancingthe shunt results in a flow path from the anterior chamber of the eye toan area of lower pressure.
 4. The method according to claim 1, whereinthe area of lower pressure is selected from the group consisting of:intra-tenon's space, the subconjunctival space, the episcleral vein, thesuprachoroidal space, and Schlemm's canal.
 5. The method according toclaim 1, wherein the inserting step comprises inserting the devicethrough the cornea.
 6. The method according to claim 1, wherein theoptical apparatus is a goniolens.
 7. The method according to claim 1,wherein the advancing occurs without use of an optical apparatus thatcontacts the eye.
 8. The method according to claim 1, wherein theposition is at the trabecular meshwork of the eye.
 9. The methodaccording to claim 1, wherein the eye tissue comprises sclera.
 10. Amethod for deploying a shunt within an eye, the method comprising:inserting into an eye a deployment device configured to hold anintraocular shunt; advancing, without use of an optical apparatus thatcontacts the eye, the device until a protrusion on a distal end of ahousing of the device contacts an anatomical structure at the anteriorchamber angle of the eye, thereby providing resistance against furtheradvancement of the device; and advancing the shunt from the device intothe eye.
 11. The method according to claim 10, wherein a distal portionof the housing comprises a sleeve and a hollow shaft that is movablewithin the sleeve, and further comprising distally advancing the hollowshaft relative to the sleeve after the advancing the device until theprotrusion contacts the anatomical structure.
 12. The method accordingto claim 11, wherein the protrusion is formed integrally with a distalend of the sleeve.
 13. The method according to claim 11, wherein theprotrusion is connected to a distal end of the sleeve.
 14. The methodaccording to claim 11, wherein the protrusion surrounds the distal endof the sleeve.
 15. The method according to claim 11, wherein theprotrusion extends around only a portion of the sleeve.
 16. The methodaccording to claim 10, wherein the inserting step comprises insertingthe device through the cornea.
 17. A method, for treating an eye,comprising positioning an intraocular shunt in eye tissue, without useof an optical apparatus that contacts the eye, such that the shuntconducts fluid from the anterior chamber of the eye.
 18. The methodaccording to claim 17, wherein the positioning comprises inserting adeployment device, configured to hold the intraocular shunt, into theeye, and thereafter advancing the deployment device into the eye untilan increased resistance against further advancement is encountered. 19.The method according to claim 18, wherein the inserting step comprisesinserting the device through the cornea.
 20. The method according toclaim 17, wherein the positioning results in a flow path from theanterior chamber of the eye to a region of the eye having a lowerpressure than has the anterior chamber.
 21. The method according toclaim 17, wherein the region is selected from the group consisting of:intra-tenon's space, the subconjunctival space, the episcleral vein, thesuprachoroidal space, and Schlemm's canal.
 22. The method according toclaim 17, wherein the optical apparatus is a goniolens.